Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT Angiography
Recruiting now · Not applicable
Conditions studied: Coronary Artery Disease, CT Angiography, PCSK9, Cardiovascular Events
In brief
The primary objective was to evaluate the effect of PCSK9 inhibitors in addition to the background lipid-modifying therapy (LMT), compared with standard LMT in terms of clinical outcomes in patients with coronary CT angiography (CCTA)-detected high-risk plaques.
Key facts
- Study ID
- NCT06863545
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 3596
- Starts
- 2025-04-22
- Expected to finish
- 2033-04-01
- Last updated by the study team
- 2026-02-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject must be ≥ 18 years.
- Patients with at least one target lesion meet CCTA-detected plaque features of the following:
- Degree of stenosis ≥ 50% or plaque burden ≥ 70%
- At least 2 of the following high-risk plaque features:
- i. Low-attenuation plaque ii. Positive remodeling iii. Napkin-ring sign iv. Spotty calcium
- The target lesion is located at the proximal or mid segment of left anterior descending artery, left circumflex artery or right coronary artery.
- Subject is able to confirm his/her understanding of the risks, benefits, and treatment alternatives of receiving study-related treatment. He/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure.
You may not qualify if…
- Target lesions underwent or planned to revascularization.
- Patients with acute coronary syndrome.
- New York Heart Association class III or IV, or last known left ventricular ejection fraction < 30%.
- Uncontrolled or recurrent ventricular tachycardia.
- Homozygous familial hypercholesterolemia.
- Active liver disease or hepatic dysfunction.
- Failed CCTA plaque analysis.
- Non-cardiac co-morbid conditions with life expectancy < 2 years.
- Pregnant and/or lactating women.
- Known hypersensitivity or contraindication to statin or PCSK9 inhibitors.
Where it is running
- Zhejiang Provincial Hospital of Traditional Chinese Medicine — Hangzhou, Zhejiang, China (enrolling)
- Hangzhou Linping First People's Hospital — Hangzhou, China (enrolling)
- The Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, China (enrolling)
- Zhejiang Hospital — Hangzhou, China (enrolling)
- Jinhua Central Hospital — Jinhua, China (enrolling)
- Seoul National University Hospital — Seoul, South Korea
Full record on ClinicalTrials.gov
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